Atlas FDA

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

FDA 510(k) clearance K233801 · decided 2024-08-23

Clearance details

K-number
K233801
Device name
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
Applicant
Boston Scientific Neuromodulation
Decision
Substantially Equivalent
Date received
2023-11-29
Decision date
2024-08-23
Days to decision
268 days
Clearance type
Traditional
Product code
GZB
Device class
2
Regulation number
882.5880
Medical specialty
Neurology
Advisory committee
Neurology
Location
Valencia, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Nalu Neurostimulation System (K221376)Boston Scientific Neuromodulation2022-06-10
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Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (K180981)Stimwave Technologies Incorporated2018-09-19
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base (K172644)Stimwave Technologies Incorporated2017-11-03
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (K170141)Stimwave Technologies Incorporated2017-05-02
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Superion Indirect Decompression System (IDS) System (P140004/S034)Boston Scientific Neuromodulation2024-11-07
Superion Indirect Decompression System (P140004/S033)Boston Scientific Neuromodulation2024-08-22
Superion Indirect Decompression System (IDS) (P140004/S032)Boston Scientific Neuromodulation2024-02-29
Superion Indirect Decompression System (IDS) (P140004/S030)Boston Scientific Neuromodulation2023-05-11
Superion Indirect Decompression System (P140004/S029)Boston Scientific Neuromodulation2023-01-06
Vertiflex Instrument Platform (VIP) Kit (P140004/S028)Boston Scientific Neuromodulation2022-03-02
Superion Indirect Decompression System (P140004/S027)Boston Scientific Neuromodulation2022-02-08
Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit (P140004/S026)Boston Scientific Neuromodulation2021-10-07